A Medical Device Daily

Orthovita (Malvern, Pennsylvania), a developer of orthopedic biomaterials, reported entering into a license agreement for Vitagel Surgical Hemostat with Angiotech Pharmaceuticals (Vancouver, British Columbia).

Vitagel is a surgical hemostat used as an adjunct to hemostasis when control of bleeding by conventional procedures is impractical. It targets a $700 million worldwide market. Agreement terms include completion of the contractual transfer of manufacturing responsibilities from Angiotech to Orthovita; the extension of the contract term from 2009 to 2014; expansion of distribution rights to Orthovita of the product in Europe and the rest of world; the retention by Orthovita of worldwide exclusive rights within orthopedics through 2014 and co-exclusive rights outside of orthopedics beginning in 2007 where Angiotech may distribute its own brand of the surgical hemostat on a co-exclusive basis outside of orthopedics; and retention by Angiotech of exclusive rights to any drug-loaded version of the surgical hemostat.

Orthovita will manufacture the hemostat product for both companies.

Orthovita has submitted a premarket application for Vitagel to the FDA in November of 2005 to allow Orthovita to sell Vitagel that is manufactured on-site at its Malvern, facility. Orthovita said it expects an FDA determination in the second half of 2006.

Orthovita has been distributing Vitagel since 1Q05 through a distribution agreement with Angiotech. Orthovita will continue to distribute Vitagel product that was produced by Angiotech prior to the closing of its manufacturing facility in November 2005.

Vitagel works by combining a thrombin/collagen suspension with the patient's own plasma. The resultant fibrin/collagen clot stems bleeding and provides a robust 3-D matrix for soft tissue healing.

In other agreement news, Neuro-Hitech Pharmaceuticals (New York), a company developing Huperzine A (HupA) and its analogues for Alzheimer's disease and other degenerative neurological disorders, reported signing a development agreement with Xel Herbaceuticals (Salt Lake City) to develop a transdermal patch to treat Alzheimer's.

HupA is a molecule undergoing Phase II clinical testing as an orally administered treatment for mild-to-moderate Alzheimer's disease.

Reuben Seltzer, president and CEO of Neuro-Hitech, said, “A transdermal patch is the ideal way to deliver any Alzheimer's treatment for several reasons. First, because of the nature of the disease, patients often forget to take their medication; a transdermal patch may provide the drug for up to a week meaning greater compliance. Second, because transdermal delivery is a more efficient way to deliver the drug, avoiding the gastrointestinal tract, more drug gets into the bloodstream meaning a smaller dose size is needed to treat the condition.“

Neuro-Hitech said it expects to complete the current Phase II trials by the end of 2006, with data available in early 2007. If preliminary indications are confirmed that HupA is better tolerated and more effective, the company said it intends to embark on a Phase III study. The transdermal patch development will trail this clinical path.